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Compares treatment options for Melanoma
Official title Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
ClinicalTrials.gov ID: NCT06008106
What this study is testing
What is tunlametinib?
tunlametinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age.
- Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology.
- History of immunotherapy failure or could not tolerate immunotherapy
- NRAS mutation at baseline;.
- There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
You likely can't join if
- Exclusion Criteria:
- Having the following treatment before receiving the study drug: ① received chemotherapy, targeted therapy or other study drug treatment within 4...
- The toxic reactions of previous anti-tumor treatment have not been recovered;
- Current use of other anti-cancer drugs.
- people with symptomatic or untreated brain metastasis, meningeal metastasis or spinal cord compression except for people with asymptomatic brain...
- History of any of the following within 6 months of screening: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass...
See the full eligibility criteria
- ≥ 18 years of age.
- Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology.
- History of immunotherapy failure or could not tolerate immunotherapy
- NRAS mutation at baseline;.
- There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Eastern cooperative oncology group (ECOG) performance status of grade 0-1.
- Life expectancy \> 3 months.
- No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 4weeks prior to investigational drug administration.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings.
- Key laboratory tests must be conducted within 7 days before dosing and meet the
- Able to understand and voluntarily sign the Informed Consent Form.
- Patients must be willing and able to complete the study procedure and follow-up examination.
- Exclusion Criteria:
- Having the following treatment before receiving the study drug: ① received chemotherapy, targeted therapy or other study drug treatment within 4 weeks before the first administration or within 5 half lives of the drug...
- The toxic reactions of previous anti-tumor treatment have not been recovered;
- Current use of other anti-cancer drugs.
- people with symptomatic or untreated brain metastasis, meningeal metastasis or spinal cord compression except for people with asymptomatic brain metastasis;
- History of any of the following within 6 months of screening: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, severe heart arrhythmia...
- ECG Corrected Q-T interval formula (QTcB) ≥ 480 msec (adjusted by Bazett's formula) during screening, or a history of congenital long QT syndrome.
- History or current evidence of retinal diseases;
- Previous or current neuromuscular diseases related to CK elevation;
- Previous or current interstitial lung disease or interstitial pneumonitis;
- Uncontrolled concomitant diseases or infectious diseases.
- Bleeding symptoms of grade 3 as defined by the National Cancer Institute General Terminology Standard for Adverse Events (NCI CTCAE V5.0) within the 4 weeks prior to study initiation.
- Inability to swallow the capsule, refractory nausea and vomiting, malabsorption, external biliary diversion, or any small intestinal resection that would preclude adequate absorption of the study drug.
- Patients who are receiving and cannot discontinue regimen-prohibited intravenous or oral drugs that affect CYP isoenzymes (strong inducers and strong inhibitors of CYP2C9) at least 1 week prior to initiation of study...
- Patients with a history of malignancy within the past 5 years;
- Human immunodeficiency virus (HIV) antibody positive; syphilis antibody (anti-TP) positive; Hepatitis C virus (HCV) antibody positive and HCV RNA positive; HBsAg positive and HBV DNA positive.
- Patients who have been previously treated with MEK inhibitors.
- Patients with known hypersensitivity to investigational drug, proposed chemotherapy or their analogues.
- History of allogeneic bone marrow transplantation or organ transplantation.
- Serum pregnancy test results are positive for premenopausal female patients;
- Other severe, acute, or chronic clinical or psychiatric disorders or laboratory abnormalities that may increase the risk and interfere with the study results in the opinion of investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.